Bivona 670190Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 15021312006094), received between Jun 19, 2017 and Sep 21, 2026 — classified as 6 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Leak/Splash

  A cuff leakage was identified on the 21st day of use while the device was in use on a patient at the hospital. The issue was resolved by replacing the device with another unit. Although the patient was involved at the time of the event, no patient harm or adverse effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838933 ↗
• MalfunctionMay 8, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUFF TORE AND LEAKED FLUID. THE CANNULA WAS IN USE FOR APPROXIMATELY FOUR WEEKS AND IT WAS REMOVED AND CLEANED ABOUT TWICE DURING THAT TIME. THE ISSUE OCCURRED ONE HOUR AFTER THE CANNULA WAS INSERTED. A NEW CANNULA WAS INSERTED IMMEDIATELY. THE INCIDENT OCCURRED WHILE IN USE WITH THE PATIENT, AT AN INTENSIVE CARE SHARED LIVING COMMUNITY. THE OPERATOR OF THE DEVICE AT THE TIME OF THE INCIDENT WAS A HEALTHCARE PROFESSIONAL. THERE WAS NO HUMAN HARM OR ADVERSE EVENT, AND NO MEDICAL INTERVENTION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129459 ↗
• MalfunctionApr 4, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT WATER COULD NOT BE INJECTED INTO THE CUFF AFTER BEING USED FOR ONE WEEK. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS UNKNOWN PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777713 ↗
• MalfunctionApr 25, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component

  IT WAS REPORTED THAT THE CUFF LEAKS. SIGNIFICANT ASYMMETRY ALSO OBSERVED AFTER A PRE-TEST OF BALLOON WITH AIR. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO INJURY, BUT THERE WAS NEEDED OF MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19185362 ↗
• MalfunctionApr 10, 2023Crack; Fracture; Defective Component; Crack; Fracture; Defective Component

  ADDITIONAL INFORMATION RECEIVED 13-APR-2023: ON 18-MAR 2023 - THE CUFF BURST/HAIRLINE CRACK AND A NEW CANNULA WAS INSERTED. IT WAS ALSO REPORTED THAT NEVER BEFORE HAS THE "CUFF BURST/HAIRLINE FRACTURE" IN TEN (10) YEARS OF VENTILATION.

  Patient problems: Insufficient Information

  MAUDE report 16710061 ↗
• MalfunctionApr 10, 2023Crack; Fracture; Defective Component; Crack; Fracture; Defective Component

  IT WAS REPORTED THAT WHILE IN USE WITH A PATIENT, THE DEVICE CUFF WAS "DEFECTIVE". THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16710037 ↗
• MalfunctionApr 10, 2023Crack; Fracture; Defective Component; Crack; Fracture; Defective Component

  IT WAS REPORTED THAT WHILE IN USE WITH A PATIENT, THE DEVICE CUFF WAS DEFECTIVE. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16710004 ↗
• MalfunctionJan 6, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE WAS FOUND LEAKING AFTER 12 HOURS OF USAGE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13175645 ↗
• InjurySep 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUFF WAS FUNCTIONING NORMALLY DURING THE PRE-TEST, BUT THE VENTILATOR ALARMED AFTER THE TUBE WAS PLACED. THREE DAYS LATER, THE CUFF WAS FOUND LEAKING. NO POLYP WAS FOUND THROUGH BRONCHOSCOPY EXAMINATION. A TRACH CHANGE WAS DONE TO RESOLVE THE ISSUE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418151 ↗
• InjuryApr 30, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF COMPONENT OF BIVONA TRACHEOSTOMY TUBE WAS NOT INFLATING. THE PLASTIC IN THE PILOT BALLOON WAS JAMMED. THE TRACHEOSTOMY TUBE WAS CHANGED AS A RESULT. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752909 ↗
• MalfunctionJan 14, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THE DEVICE CUFF DID NOT INFLATE SYMMETRICALLY. THE REPORTER STATED T16 ML OF FLUID HAD TO BE ADDED UNTIL AN ADEQUATE TRACHEAL SEAL WAS OBTAINED. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11171407 ↗
• MalfunctionJan 5, 2021Leak/Splash; Leak/Splash

  CUSTOMER NOTICED A HOLE IN THE CUFF AND THEREFORE NO WATER COULD BE HELD IN TO BLOCK. THIS WAS NOTICED AFTER TWO CLEANING CYCLES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 11120864 ↗
• MalfunctionJan 5, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHEN A CANNULA WAS INSERTED INTO THE PATIENT AFTER INITIAL PREPARATION ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. DURING THE ATTEMPT TO FILL THE TTS CUFF WITH WATER, A SMALL HOLE WAS FOUND IN THE PILOT BALLOON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11118557 ↗
• InjuryApr 5, 2020Inflation Problem; Infusion or Flow Problem; Inflation Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BLUE LINE ENDOTRACHEAL CUFFED TUBE DID NOT INFLATE CORRECTLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9927178 ↗
• InjuryApr 5, 2020Inflation Problem; Infusion or Flow Problem; Inflation Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BLUE LINE ENDOTRACHEAL CUFFED TUBE DID NOT INFLATE CORRECTLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9927177 ↗
• InjuryAug 17, 2019Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BLUE LINE ENDOTRACHEAL CUFFED TUBE WAS OBSTRUCTED AFTER A FEW MINUTES OF BEING IN USE, THE VENTILATOR ALARM SOUNDED FOR HIGH AIRWAY PRESSURES (41CM WATER) AND MINIMAL TIDAL VOLUMES (60-80ML PER BREATH) WERE DELIVERED, SAME WITH HAND VENTILATION. OXYGEN SATURATIONS AND BLOOD PRESSURE WERE STABLE. DOCTOR ATTEMPTED TO PASS A SUCTION CATHETER INTO ENDOTRACHEAL TUBE, WHICH WOULD NOT ADVANCE PAST 5 CM. AT CLOSER INSPECTION OF PATIENT'S MOUTH, TUBE NOTED TO BE KINKED AT THE BACK OF THE MOUTH. TUBE EXCHANGED FOR A DIFFERENT ENDOTRACHEAL TUBE. NO FURTHER PROBLEMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8903979 ↗
• InjuryJul 31, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER TWO MONTHS OF USE, LEAKAGE OCCURRED FROM THE PILOT BALLOON OF THE BIVONA TRACHEOSTOMY TUBE. THE TRACH WAS SWAPPED FOR ANOTHER BIVONA TUBE, AFTER WHICH THERE WERE NO FURTHER ISSUES. NO FURTHER COMPLICATIONS WERE REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7737201 ↗
• MalfunctionJun 21, 2018Air Leak; Air Leak

  INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING TWO HOURS OF USE OF A SMITHS MEDICAL PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE AN AIR LEAK WAS NOTED. THE TRACHEOSTOMY (TRACH) WAS REQUIRED TO BE CHANGED OUT WITH NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7626577 ↗
• MalfunctionJun 19, 2017Fluid/Blood Leak; Hole In Material; Fluid/Blood Leak; Hole In Material

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LEAK IN THE CUFF OF A PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE. AFTER NOTICING THE LEAK, THE PATIENT WENT INTO THE HOSPITAL AND HAD THE TRACHEOSTOMY TUBE REPLACED. THE STAFF IN THE HOSPITAL FILLED THE CUFF, AND OBSERVED WATER SLOWLY LEAKING OUT OF A SMALL HOLE. THE CUFF HAD BEEN CHECKED PRIOR TO BE INSERTED IN THE PATIENT, HOWEVER IT WAS IT NOTED THAT BECAUSE THE HOLE WAS SMALL, NO LEAKAGE WAS OBSERVED DURING THAT CHECK. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6651178 ↗